WO2012082425A2 - Manchon d'injection avec de multiples couches de matériau - Google Patents

Manchon d'injection avec de multiples couches de matériau Download PDF

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Publication number
WO2012082425A2
WO2012082425A2 PCT/US2011/063242 US2011063242W WO2012082425A2 WO 2012082425 A2 WO2012082425 A2 WO 2012082425A2 US 2011063242 W US2011063242 W US 2011063242W WO 2012082425 A2 WO2012082425 A2 WO 2012082425A2
Authority
WO
WIPO (PCT)
Prior art keywords
phacoemulsification
infusion sleeve
sleeve
friction
shore
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2011/063242
Other languages
English (en)
Other versions
WO2012082425A3 (fr
Inventor
Grace Chuang Liao
Karen T. Hong
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alcon Research LLC
Original Assignee
Alcon Research LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alcon Research LLC filed Critical Alcon Research LLC
Priority to CN201180060018.5A priority Critical patent/CN103260559B/zh
Priority to AU2011341430A priority patent/AU2011341430B2/en
Priority to ES11848030.0T priority patent/ES2585399T3/es
Priority to EP11848030.0A priority patent/EP2651486B9/fr
Priority to JP2013544545A priority patent/JP2014505514A/ja
Priority to CA2817762A priority patent/CA2817762C/fr
Publication of WO2012082425A2 publication Critical patent/WO2012082425A2/fr
Anticipated expiration legal-status Critical
Publication of WO2012082425A3 publication Critical patent/WO2012082425A3/fr
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • A61F9/00745—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments using mechanical vibrations, e.g. ultrasonic

Definitions

  • the present disclosure generally relates to the field of
  • phacoemulsification and more specifically the field of infusion sleeves.
  • Typical phacoemulsification ultrasonic surgical devices consist of an ultrasonically driven handpiece with an attached cutting tip and irrigating sleeve, also known as an infusion sleeve, with an electronic control module.
  • the handpiece generally includes an irrigation line, aspiration line and a power cord, all of which are generally interconnected to, and controlled by, the control module.
  • the cutting tip and attached infusion sleeve are inserted into a small incision in a cornea, or other location.
  • the control module varies a power level in the handpiece to ultrasonically vibrate the cutting tip, while providing irrigation between the infusion sleeve and cutting tip.
  • the control module also provides a vacuum through a port in the cutting tip.
  • the infusion sleeve is the only part, other than the cutting tip, that comes into contact with a patient.
  • the infusion sleeve's operability is extremely important for the overall performance of the phacoemulsification equipment.
  • One concern in phacoemulsification surgical procedures is the problem of heat build-up in the cutting tip. Wound pressure on the infusion sleeve walls compresses the walls and causes both reduced fluid flow to and from the cutting tip and heat-producing frictional contact between the vibrating cutting tip and the walls of the infusion sleeve. Thus, as cooling fluid flow is diminished, frictional heat increases without a means to dissipate the heat. The heat build-up can cause scleral or corneal bums very quickly.
  • corneal bums may be mitigated by a surgeon through appropriate adjustments of a combination of operating parameters, such as the amount of phaco power delivered and the volume of irrigation/aspiration flow.
  • some prior art handpiece assemblies or probes generally have relied solely on a textured inner sleeve wall and the flow of the irrigant between the cutting tip and the sleeve and the flow of aspirated material into the cutting tip bore to cool the cutting tip.
  • a viscoelastic material injected into the anterior ocular chamber during a typical phacoemulsification procedure resists the flow of the irrigant out of the sleeve and is highly resistant to aspiration flow into the cutting tip bore. Therefore, the flow of aspiration and irrigation fluids into and out of the eye can be momentarily occluded whenever the cutting tip and sleeve come into contact with the viscoelastic material. This momentary occlusion can result in sudden cutting tip overheating and resultant scleral and/or corneal lesions. Thus, because cutting tip overheating occurs very rapidly (within 1 to 3 seconds), even short term exposure to such overheating can cause injury to delicate eye tissue.
  • a Mackool tip is a two part infusion sleeve having an inner rigid sleeve that is inserted into and surrounded by an outer malleable sleeve.
  • the inner rigid sleeve is considered as part of the Mackool phaco tip and sits loosely on a main shaft portion of the Mackool phaco tip.
  • the purpose of the inner rigid sleeve is to decouple the vibrating needle from the infusion sleeve.
  • the inclusion of the inner rigid sleeve results in a much more dramatic reduction of heat.
  • a phacoemulsification system includes a phacoemulsification handpiece and selectively detachable infusion sleeve.
  • the infusion sleeve may include a single body portion defined by a first open end and a second open end and having a hollow interior portion therein.
  • the body portion may include multiple layers with at least one inner layer and at least one outer layer, such that the layers are constructed of separate and distinct materials.
  • FIG. 1 is a perspective view of an exemplary phacoemulsification handpiece assembly
  • FIG. 2 is an enlarged perspective view of an exemplary multi-layer infusion sleeve engaged with the phacoemulsification handpiece of FIG. 1 ;
  • FIG. 3 is a perspective cut-away view of the exemplary multi-layer infusion sleeve of FIG. 2, illustrating internal areas of the infusion sleeve;
  • FIG. 4 is an enlarged perspective cut-away view of the exemplary multilayer infusion sleeve of FIG. 3, illustrating the multiple layers of the infusion sleeve.
  • FIG. 5 is an enlarged cut-away view of a portion of the exemplary multilayer infusion sleeve with raised protrusions for friction relieving elements.
  • FIG. 6 is an enlarged cut-away view of a portion of the exemplary multilayer infusion sleeve with recessed valleys for friction relieving elements.
  • FIG. 7 is an enlarged cut-away view of a portion of the exemplary multilayer infusion sleeve with a low friction coating for the friction relieving element.
  • the phacoemulsification device 10 is defined by a distal end 12 and a proximal end 14, with a hollow handpiece body portion 16 spanning therebetween.
  • the body portion 16 may be rotatively interconnected at the distal end 12 with an irrigation infusion sleeve 50 (best seen in FIG. 2).
  • the body portion 16 may generally include an ultrasonically driven internal cannula 20 that extends internally from the proximal end 14 to an integrated cutting tip 22 at the distal end 12.
  • the internal cannula 20 may be in communication with a power cord 30, which controls power for ultrasonic vibrations of the cutting tip 22 and an aspiration line 32 for removal of emulsified cataract tissue or aspirant. Additionally, an irrigation line 34 may be fluidly connected to a tube 56, having a hollow area 60, (best seen in FIGS 3 and 4) between an inner surface 62 of the infusion sleeve 50 and an outer surface of the cannula 20.
  • the infusion sleeve 50 may be attached directly fixed to the distal end 12 of the body portion 16 of the phacoemulsification device 10.
  • the infusion sleeve 50 may generally include a main body or base section 52 that extends from a connection at the distal end 12 of the body portion 16 to a conical nose section 54 that tapers down from the base section 52 to an elongated tube section 56.
  • the infusion sleeve 50 generally includes the hollow area 60 that extends interiorly from the base section 52 to a tapered tip 58.
  • the tapered tip 58 may include one or more fluid ports 70 that fluidly connect the inner hollow area 60 with an incision in the corneal area.
  • the infusion sleeve 50 may also include protrusions 66 (best seen in FIG. 2) extending from an outer surface 64 of the infusion sleeve 50 at the conical nose section 54 or the base section 52.
  • the protrusions 66 may provide rigidity and added grip for handling the phacoemulsification device 10.
  • FIGS. 3 and 4 an exemplary fusion sleeve 50 is illustrated in cross-section.
  • the infusion sleeve 50 includes threads 68 for rotatively connecting the infusion sleeve 50 to the body portion 16.
  • other connecting elements may be used, such as, but not limited to, tongue and groove arrangements, latching male and female tabs, twist lock male tabs and corresponding female receptacles (i.e., luer-type arrangements) and other known elements that provide a sealing connection between the infusion sleeve 50 and the body portion 16.
  • the inner hollow area 60 may be seen as it transitions from the threaded portion 68 and tapers down to the tapered tip 58, where the fluid ports 70 are positioned.
  • the fluid ports 70 may be positioned about an outer periphery of the tapered tip 58.
  • the fluid ports 70 may be of any size and of any shape depending on the application. As illustrated, the fluid ports 70 are circular apertures that are positioned on opposing sides.
  • the outer surface layer 64 extends the length of the infusion sleeve 50 and may be made with materials that provide a minimization of heat and motion transfer.
  • outer surface layer 64 materials may include, but are not limited to, a silicone, a polyimide, a polyethylene and an acetal. Each material may have a specific equivalent durometer range (discussed below) with a general thermal conductivity in the range of 0.1 - 0.9 W/(m*°K).
  • silicone may have a durometer ranging from 30 - 80 Shore A
  • polyimide may have a durometer ranging from 65 - 92 Shore D
  • polyethylene may have a durometer ranging from 45 - 53 Shore D
  • acetal may have a durometer ranging from 70 - 88 Shore D.
  • the durometer of the outer layer material will be lower than the durometer of the inner layer material, as the inner layer is more rigid than the outer layer.
  • the outer surface layer 64 may be used to minimize the heat and motion transfer that may be transmitted to the cornea, which may help reduce the likelihood of corneal burns and mechanical trauma during a phacoemulsification surgery procedure.
  • the softer material used may also provide better sealing about the incision, thereby reducing any incisional leakage that may occur.
  • the inner surface layer 62 may be made with materials providing a relatively stiff surface that may have a relatively low coefficient of friction such that the surface friction is minimized against the vibrating cutting tip 22.
  • such inner surface layer 62 materials may include, but are not limited to an injection-moldable polyimide, and an acetal. These materials may typically have a coefficient of friction value approximately in a range of 0.1 to 0.3.
  • the inner surface layer 62 may also include mechanical features, such as, but not limited to, bumps 80 (see FIG. 5), ribs, ridges, recessed valleys 82 (see FIG. 6), or other such friction relieving elements causing a random disruption in the inner surface layer 62.
  • the mechanical features may be used in conjunction with specific manufacturing materials that are different than that of the outer surface 64.
  • the inner surface layer 62 may include (either separately or in combination with one or more other friction relieving elements) a low-friction coating 84 (see FIG.
  • the coating may be, but is not limited to a parylene N or other types of parylene coatings and a FluoroBond® LSR (Orion Industries) or other known fluoropolymer coatings generally having a coefficient of friction approximately in the range of 0.1 to 0.3.
  • the layer materials, mechanical features and coatings may be used simultaneously or each may be used individually. In some embodiments, at least two different layers are used and the inner layer material is more rigid than the outer layer material.
  • the two layers 62, 64 may be created using multi-layer injection molding or overmolding processes.
  • multi-component, multi-shot and over-molding process may be employed to create a multiple layered infusion sleeve in a unitary construction.
  • Multi-component molding may be further subdivided into co-injection, bi-injection and interval injection.
  • Co-injection molding involves making sequential injections into the same mold with one material as the core and one as the skin. It may also be known as sandwich molding because the core is fully encapsulated.
  • Bi- injection molding is the simultaneous injection of different materials through different gates.
  • Interval injection molding also known as marbling, is the simultaneous injection of different materials through different gates giving limited mixing.
  • Multi-shot molding describes any process where distinct material shots are applied to produce the final component. This includes transfer molding, injection molding, core back molding and rotating tool molding. Where multiple slugs of different materials may be injected into the mold to create the multiple layered product.
  • Over-molding includes both insert molding and lost core molding, the latter produces hollow parts. Over-molding allows the desired part to be preformed and then reinserted into a mold for an additional layer of material to be applied to the original part.
  • the infusion sleeve threads 68 may be rotatively engaged with corresponding threads in the body portion 16 to lock the two pieces as one unit.
  • Further assembly includes attaching the aspiration line 32, irrigation line 34 and power cord 30 to the control module to create a phacoemulsification assembly.
  • the infusion sleeve 50 may be of various diameters and lengths to accommodate specific phacoemulsification cannula 20 and body portions 16.
  • Infusion sleeve 50 selection may include selecting a sleeve to allow the cutting tip 22 to extend a predetermined distance from the end of the infusion sleeve 50 to allow for proper alignment of the cutting tip 22 extending past the fluid ports 70. This may allow the cutting tip 22 to provide enough ultrasonic vibration to breakup or emulsify the cataract and draw in just the cataract tissue and not draw additional liquid from the incision. This predetermined distance may also help to eliminate any irrigant from being drawn directly from the hollow area 60 within the infusion sleeve 50.
  • an operator may activate the control module to cause the phacoemulsification device cannula 20 to vibrate ultrasonically, and these vibrations are transmitted along to the cutting tip 22 where the vibrations are used to fracture or emulsify a cataract or other phaco-type tissue.
  • a vacuum source may be activated to draw the emulsified tissue or aspirant through a central lumen 24 in the cannula 20 (illustrated in FIGS. 1 and 2) starting at the cutting tip 22 and extending through the body portion 16 to a flexible aspiration line 32 that extends to the control module.
  • An irrigant source supplies an irrigant such as saline solution under pressure through irrigation line 34 and that extends along the body portion 16 to the hollow area 60 in the infusion sleeve 50 where the irrigant is forced to migrate along the inner surface layer 62 in the tube 56 between the tube 56 and the cannula 20.
  • the tube 56 may be dimensioned to fit securely around the cannula 20, which allows the irrigant to exit the infusion sleeve 50 through the fluid ports 70 to provide lubrication to the incision area.
  • the exemplary infusion sleeve 50 may be constructed with an additional layer 72 of material, as illustrated in FIG. 4.
  • the additional layer 72 may provide additional friction-relieving properties, additional heat resistance properties, or a combination thereof, as discussed above regarding the materials used in producing the multi-layered infusion sleeve 50. These additional requirements may depend upon the predetermined and desired applications. It should be known that when the mechanical elements are used, the amount of frictional contact area between the cannula 20 and the inner surface 62 may be reduced/minimized to lower the frictional heat created by the vibrations.
  • an additional lubricity may be retained due to material selection or by retaining the irrigant within the recesses of the elements to continuously supply a small amount of irrigant even if the main flow of irrigant is interrupted, thereby continuously bathing the cannula 20 and ultimately the cutting tip 22 with the lubricating irrigant.

Landscapes

  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention porte sur un système de phaco-émulsification. Le système comprend une pièce à main de phaco-émulsification et un manchon d'injection détachable de façon sélective. Le manchon d'injection peut comprendre une partie corps unique définie par une première extrémité ouverte et une seconde extrémité ouverte, et ayant à l'intérieur de celle-ci une partie intérieure creuse. La partie corps peut comprendre de multiples couches avec au moins une couche interne et au moins une couche externe, de telle sorte que les couches sont construites en des matériaux séparés et distincts.
PCT/US2011/063242 2010-12-15 2011-12-05 Manchon d'injection avec de multiples couches de matériau Ceased WO2012082425A2 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CN201180060018.5A CN103260559B (zh) 2010-12-15 2011-12-05 具有多个材料层的输注套筒
AU2011341430A AU2011341430B2 (en) 2010-12-15 2011-12-05 Infusion sleeve with multiple material layers
ES11848030.0T ES2585399T3 (es) 2010-12-15 2011-12-05 Manguito de infusión con múltiples capas de material
EP11848030.0A EP2651486B9 (fr) 2010-12-15 2011-12-05 Manchon d'infusion avec de multiples couches de matériau
JP2013544545A JP2014505514A (ja) 2010-12-15 2011-12-05 多重材料層を有する注入スリーブ
CA2817762A CA2817762C (fr) 2010-12-15 2011-12-05 Manchon d'injection avec de multiples couches de materiau

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US42318310P 2010-12-15 2010-12-15
US61/423,183 2010-12-15

Publications (2)

Publication Number Publication Date
WO2012082425A2 true WO2012082425A2 (fr) 2012-06-21
WO2012082425A3 WO2012082425A3 (fr) 2013-07-18

Family

ID=46235314

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2011/063242 Ceased WO2012082425A2 (fr) 2010-12-15 2011-12-05 Manchon d'injection avec de multiples couches de matériau

Country Status (8)

Country Link
US (1) US20120157934A1 (fr)
EP (1) EP2651486B9 (fr)
JP (1) JP2014505514A (fr)
CN (1) CN103260559B (fr)
AU (1) AU2011341430B2 (fr)
CA (1) CA2817762C (fr)
ES (1) ES2585399T3 (fr)
WO (1) WO2012082425A2 (fr)

Cited By (2)

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CN103549976A (zh) * 2013-11-11 2014-02-05 深圳市开立科技有限公司 一种超声探头、医用内镜及其加工方法
US8852091B2 (en) 2012-04-04 2014-10-07 Alcon Research, Ltd. Devices, systems, and methods for pupil expansion

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US10213533B2 (en) * 2012-03-05 2019-02-26 Keith A. Walter Medical tools with aspiration tips suitable for cataract surgeries and related methods
US20130289469A1 (en) * 2012-04-26 2013-10-31 Karen T. Hong Infusion Sleeve With Motion Reduction Profile
US10220186B2 (en) * 2012-05-23 2019-03-05 Becton, Dickinson And Company Collapse-resistant swellable catheter
US9610193B2 (en) 2013-12-05 2017-04-04 Novartis Ag Forward flow impeding infusion sleeve and associated systems and methods
US9731065B2 (en) 2013-12-05 2017-08-15 Novartis Ag Devices, systems, and methods for tip vacuum control during aspiration
US20150313755A1 (en) * 2014-05-02 2015-11-05 Alcon Research, Ltd. Ophthalmic surgical instrument with internal frame and external coating
EP3137026B1 (fr) 2014-05-02 2020-07-22 ART, Ltd. Appareil de phaco-émulsification
WO2017007655A1 (fr) * 2015-07-08 2017-01-12 Depenbusch Michael Jerome Embout de phacoémulsification de la cataracte
US11058578B2 (en) * 2017-06-14 2021-07-13 Johnson & Johnson Surgical Vision, Inc. Convertible phacoemulsification i/a sleeve and mechanical activation mechanism
US11419971B2 (en) * 2017-08-28 2022-08-23 Surgical Design Corporation Ocular surgical work tip adapter
US11116890B2 (en) * 2017-08-28 2021-09-14 Surgical Design Corporation Ocular work tip sleeve adapter
CN109350353B (zh) * 2018-10-18 2023-10-17 溧阳市中医医院 中央孔型人工晶体植入术用后房粘弹剂的吸除装置及用法
EP4017439A1 (fr) * 2019-11-04 2022-06-29 Alcon Inc. Manchon d'irrigation pour interventions ophtalmiques
DE102020110438A1 (de) * 2020-04-16 2021-10-21 Tdk Electronics Ag Sensor mit Gehäuse
CN114533386B (zh) * 2020-11-24 2025-05-30 微创视神医疗科技(上海)有限公司 超声乳化针、超声乳化手柄和超声乳化针的制造方法
WO2025099525A1 (fr) * 2023-11-08 2025-05-15 Alcon Inc. Instruments chirurgicaux ayant une adhérence réduite au corps vitré

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See also references of EP2651486A4

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8852091B2 (en) 2012-04-04 2014-10-07 Alcon Research, Ltd. Devices, systems, and methods for pupil expansion
CN103549976A (zh) * 2013-11-11 2014-02-05 深圳市开立科技有限公司 一种超声探头、医用内镜及其加工方法

Also Published As

Publication number Publication date
ES2585399T3 (es) 2016-10-05
JP2014505514A (ja) 2014-03-06
CN103260559B (zh) 2016-01-06
EP2651486A2 (fr) 2013-10-23
CA2817762A1 (fr) 2012-06-21
CN103260559A (zh) 2013-08-21
AU2011341430A1 (en) 2013-06-06
WO2012082425A3 (fr) 2013-07-18
EP2651486B1 (fr) 2016-04-13
CA2817762C (fr) 2019-05-21
US20120157934A1 (en) 2012-06-21
AU2011341430B2 (en) 2016-06-30
EP2651486A4 (fr) 2014-06-11
EP2651486B9 (fr) 2018-09-26

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